This trial is active, not recruiting.

Conditions glycogen storage disorder type 1, hypoglycemia, cornstarch, glycosade
Treatment glycosade
Sponsor University of Manitoba
Collaborator Co-Investigator - Dr. Cheryl Rockman-Greenberg
Start date July 2014
End date June 2016
Trial size 8 participants
Trial identifier NCT02176096, B2013-097


The objective of this demonstration project is to compare a novel long-acting starch, Glycosade, a hydrothermally processed high amylopectin maize starch, versus gastrostomy tube-dextrose infusion in maintaining euglycaemia overnight in children with GSD-I. Glycosade has been reported to increase the duration of euglycaemia. Its slow release and longer periods of normal blood sugar achieved would preclude the need for the overnight dextrose infusion and eliminate the need for the surgical insertion of a gastrostomy tube for this purpose. Glycosade also reportedly causes fewer gastrointestinal side effects, thus potentially improving compliance to therapy. The investigators intend to evaluate Glycosade in our patients and determine its efficacy on glucose control, on the length of normoglycemia achieved and to determine if there are reduced side effects in our patients with GSD-I. This will be accomplished by an open label study of Glycosade in GSD-I patients who consent to the protocol.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose treatment
glycosade Modified starch

Primary Outcomes

Normal Blood Glucose
time frame: Overnight

Eligibility Criteria

Male or female participants from 5 years up to 18 years old.

Inclusion Criteria: - Diagnosis of GSD Type 1 - Age >5 years Exclusion Criteria: -

Additional Information

Official title Comparison of the Effect of a Novel Starch (Glycosade) Versus Gastrostomy Tube-Dextrose Infusion on Overnight Euglycaemia Control in Children With Glycogen Storage Disease Type I: Open Label Demonstration Trial
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by University of Manitoba.